FDA.reportPublic FDA data

NDC 61269-164 - Vitamins A, C, D and Fluoride Drops

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61269-164
Package NDCs from labels
61269-164-50
Manufacturer
H2-Pharma, LLC
Effective date
2025-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vitamins A, C, D and Fluoride Drops - H2-Pharma, LLCH2-Pharma, LLC2025-09-15DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-164-50Vitamins A, C, D and Fluoride Drops1 in 1 CARTONSOLUTION/ DROPS14
61269-164-50Vitamins A, C, D and Fluoride Drops50 mL in 1 BOTTLESOLUTION/ DROPS504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-164VITAMINS A, C, D AND FLUORIDE DROPS (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, AND SODIUM FLUORIDE) SOLUTION/ DROPS [H2-PHARMA, LLC]32 package rows20220202_a029ef7b-3f7e-43dc-a200-e1ca47cd6d1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-164-50ML - Milliliter61269-16485f76f98-e5a7-4535-af78-f19da21959ef12017-04-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 83 of 86 · 1,704 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLCb83c62be-8e9d-4fa2-aa10-d34c88bf23872021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC427f25e6-e50a-407a-a6f0-512123e381e42021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Wentworth Alcohol FreeSODIUM FLUORIDESheffield Pharmaceuticals LLC5ed816ef-20bc-49ac-9202-8fac1edac5792021-03-23Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm Dry MouthSODIUM FLUORIDESheffield Pharmaceuticals LLCcbc67f03-55c4-4781-ba37-87c737b602822021-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, Inc.ab9b07ad-f6b2-4289-bec4-fec58270dc972021-02-20WarningsExact identifier
unii: 8ZYQ1474W7
GUNA SINUS PLUSALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA -Guna spab48c5634-24cf-343e-e053-2995a90a3a9a2021-02-17WarningsExact identifier
unii: PQ6CK8PD0R
AvantSODIUM FLUORIDEDharma Research, Inc.4749dce1-c0b9-4737-8a30-85cd58aba21b2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AvantSODIUM FLUORIDEDharma Research, Inc.184bbe52-3909-45f6-b4d0-fe7849fabc1c2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Fluoride 5000 ppm Enamel ProtectSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC83dfdead-4f71-404e-90ae-dbd6849c7cf12021-01-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: PQ6CK8PD0R
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: PQ6CK8PD0R
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: PQ6CK8PD0R
Ionite APF NeutralSODIUM FLUORIDEDharma Research, inc.ad7a660b-274c-417e-bdf3-1d5addf06ad12020-11-18WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.8ff1b377-0535-4548-a109-f9f1a43b85b72020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e6c31330-43e0-4d32-af54-ff852af39cab2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.